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DreamWisp DreamWisp Mask, Medium, Med Connector, W/Headgear, INTLRecalls & reported problems

Respironics, Inc. · DreamWisp Nasal, Medium with Medium Connector with Headgear, International · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959051126), received between Nov 9, 2022 and Nov 9, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Patient Device Interaction Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    THE MANUFACTURER RECEIVED INFORMATION THAT THE DREAMWISP MASK WITH MAGNETIC CLIPS ALLEGEDLY CAUSED ITCHING TO THE SIDE OF THEIR NOSE AND AIR COMES OUT INTO HER FACE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION. THE DREAMWISP MASK IS INTENDED TO PROVIDE AN INTERFACE FOR APPLICATION OF CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) OR BILEVEL THERAPY TO PATIENTS. THE MASK IS INTENDED FOR SINGLE PATIENT USE IN THE HOME OR MULTI-PATIENT USE IN THE HOSPITAL/INSTITUTIONAL ENVIRONMENT. THE MASK IS TO BE USED ON PATIENTS (>66 LBS/30KG) FOR WHOM CPAP OR BI-LEVEL THERAPY HAS BEEN PRESCRIBED. THE DREAMWISP MASK INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING WARNINGS: THE HEADGEAR CLIPS CONTAIN MAGNETS. CONTACT YOUR HEALTHCARE PROFESSIONAL BEFORE YOU USE THIS MASK. SOME MEDICAL DEVICES MAY BE AFFECTED BY MAGNETIC FIELDS. THE MAGNETIC CLIPS IN THIS MASK SHOULD BE KEPT AT LEAST 2 IN. (50 MM) AWAY FROM ANY ACTIVE MEDICAL DEVICE WITH SPECIAL ATTENTION TO IMPLANTED DEVICES SUCH AS PACEMAKERS, DEFIBRILLATORS AND COCHLEAR IMPLANTS. DO NOT USE IN OR NEAR MAGNETIC RESONANCE IMAGING (MRI) EQUIPMENT. KEEP UNASS

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15759371 ↗

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Sources and updates

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